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Completed

NCT Number: NCT04998136

Research Study Investigating How Well Semaglutide Works in People From Thailand and South Korea Living With Obesity

This study looks at how well semaglutide helps people lose weight. This study will look at the change in the participants' body weight from the start to the end of the study. The study compares the weight loss in people who get semaglutide to the weight loss in people who get placebo. Placebo is a "dummy" medicine that looks like the study medicine, but has no effect on the body.

Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm.

Participants will also have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight.

The study will last for about a year (50 weeks). Participants will have 10 clinic visits and 8 phone calls. At 6 of the clinic visits participants will have blood samples taken.

Participants cannot take part if participants have or have had diabetes. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Konyang University Hospital, Daejeon, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above or equal to 18 years at the time of signing informed consent.
  • BMI at least 25.0 kg/m^2 at screening.
  • Both parents of Asian descent.
  • History of at least one self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

  • HbA1c at least 48 mmol/mol (6.5%) as measured by the central laboratory at screening.
  • History of type 1 or type 2 diabetes mellitus.
  • A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
  • Any participant where a substantial weight loss, in the investigator's opinion, might jeopardise the participant's safety.
  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 15 mL/min/1.73 m^2 at screening.

Treatment and study plan

Semaglutide 2.4 mg

Drug

Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg

Placebo (semaglutide 2.4 mg)

Drug

Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks

Primary outcomes

  1. Change in Body Weight (%) : In-trial Observation Period

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  2. Change in Body Weight (%) : On-treatment Observation Period

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.

  3. Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period

    Time frame: At week 44

    Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  4. Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period

    Time frame: At week 44

    Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses.

Secondary outcomes

  1. Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no)

    Time frame: At week 44

    Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  2. Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no)

    Time frame: At week 44

    Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  3. Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no)

    Time frame: At week 44

    Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  4. Change in Waist Circumference

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  5. Change in Body Weight (kg)

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  6. Change in Body Mass Index

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  7. Change in Systolic Blood Pressure (mmHg)

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  8. Change in Diastolic Blood Pressure

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in diastolic blood pressure from baseline (week 0) to end of the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  9. Change in Total Cholesterol (mg/dL) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  10. Change in Total Cholesterol (mmol/L) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  11. Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  12. Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  13. Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  14. Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  15. Change in Triglycerides (mg/dL) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  16. Change in Triglycerides (mmol/L) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  17. Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  18. Change in HbA1c (%)

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

  19. Change in HbA1c (mmol/Mol)

    Time frame: Baseline (week 0), end of treatment (week 44)

    Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Asians With Obesity Diagnosed as BMI ≥ 25 kg/m2 According to Local Guidelines

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2021
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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